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Tag "U.S. Food and Drug Administration"

Approving cancer treatments based on endpoints other than overall survival: an analysis of historical data using the PACE Continuous Innovation Indicators™ (CII)

Authors: Neon Brooks, Mario Campone, Silvia Paddock, Scott Shortenhaus, David Grainger, Jacqueline Zummo, Samuel Thomas, Rose Li

This article examines the relationship between U.S. Food and Drug Administration (FDA) approval and the publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available.

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